Illness Expectations in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT06509308
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
This study investigates the impact of expectations on individuals with Chronic Obstructive Pulmonary Disease (COPD) and aims to develop and validate a novel tool to assess these expectations. By understanding the role of expectations, healthcare providers can better tailor interventions and support for COPD patients, ultimately improving their quality of life and treatment outcomes.
- Detailed Description
This research, carried out at the specialized cardiorespiratory rehabilitation unit of the Don Gnocchi Foundation in Milan, delves into the influence of expectations on individuals living with Chronic Obstructive Pulmonary Disease (COPD). The primary objective is to craft and validate a fresh assessment tool to gauge these expectations. Moreover, the questionnaire is reintroduced to patients after a month, during which additional data, as detailed in the corresponding section, are gathered.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Diagnosis of COPD confirmed by spirometry
- Adults
- Italian speakers
- Ability to complete the required tests
- Informed consent from the patient to participate in the study
- Non-Italian speakers
- Psychiatric comorbidities
- Cognitive impairment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chronic Obstructive Pulmonary Disease Expectations Questionnaire From October 2023 to January 2025 A questionnaire composed of 27 items, designed by us, asking the patient to assess their disease expectations for the next 3 months. Each item is rated on a 7-point Likert scale, allowing for a nuanced evaluation of the patient's perceptions and expectations. Scores range from 27 to 189. A higher score indicates a worse illness perception.
A questionnaire composed of 27 items, designed by us, asking the patient to assess their disease expectations for the next 3 months. Each item is rated on a 7-point Likert scale, allowing for a nuanced evaluation of the patient's perceptions and expectations. Scores range from 27 to 189. A higher score indicates a worse illness perception.
- Secondary Outcome Measures
Name Time Method Socio-demographic variables From October 2023 to January 2025 Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as family history of respiratory diseases, alcohol use (frequency), physical activity (frequency and type), level of education, marital status, onset of initial symptoms, and date of diagnosis will be considered.
Body Mass Index From October 2023 to January 2025 kg/m\^2
Medical data From October 2023 to January 2025 parameters from respiratory function tests (particularly Forced Vital Capacity (FVC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), arterial blood gas analysis) will be recorded. These data will be extracted from the latest available medical report and therefore from the last pulmonary visit conducted as part of routine clinical practice (please note that medical visits paid for by this project are not included).
Brief Illness Perception Questionnaire From October 2023 to January 2025 The BIPQ is self-report questionnaire consisting of 8 items, rated on a 10-point Likert scale, investigates perceptions of illness (representations of cause, consequence, identity, control, duration), and requires the patient to nominate 3 factors they believe triggered the illness. The total score is calculated by summing the scores of all items, with a possible range of 0-80. Higher scores indicate worse illness perception. \<42 indicating low experienced threat, 42-49 indicating moderate experienced threat, and ≥50 indicating high experienced threat in patients with a recently acquired spinal cord injury.
Illness Cognition Questionnaire From October 2023 to January 2025 The ICG is a 18-item questionnaire that contains three 6-item scales related to the factors helplessness, acceptance and perceived benefits, each with a scoring range of 6-24 Helplessness (items 1, 5, 7, 9, 12, 15), Acceptance (items 2, 3, 10, 13, 14, 17), and Perceived Benefits (items 4, 6, 8, 11, 16, 18).
Chronic Obstructive Pulmonary Disease Assessment TEST From October 2023 to January 2025 The CAT is a self-report questionnaire consisting of 8 items, rated on a 6-point Likert scale, where patients are asked to rate COPD impact on their quality of life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. Scores \<10 have a low impact, 10-20 medium, 21-30 high and \>30 very high impact
Pharmacological Therapy From October 2023 to January 2025 A list of the medications taken by the patient.
Exacerbations and hospitalizations From October 2023 to January 2025 frequency of exacerbations and hospitalizations over the past year
Comorbidities From October 2023 to January 2025 A list of the major illness suffered from the patient.
Trial Locations
- Locations (1)
Don Gnocchi Foundation
🇮🇹Milan, Italy